Chapter 8

Pharmacovigilance

Regulatory approval (chapter 6) of a biosimilar is granted on the basis that its efficacy and safety have been demonstrated as equivalent to those of the reference biopharmaceutical. It is also accepted that biosimilars are not completely identical to the reference product – differences in their respective manufacturing processes (chapter 2) may lead to minor variations between biosimilars and their reference biopharmaceutical in some clinical properties, for example, their immunogenic potential.

Pre-approval, phase 3 clinical trials of biosimilar drugs conducted to establish safety and efficacy are not in general designed to predict whether, for example, post-translational modifications related to manufacturing conditions (chapter 1). Because a biosimilar is essentially the same as the reference product, any differences in its clinical performance leading to practice-related adverse effects may be rare occurrences, only detectable after prolonged exposure in many people.

In this chapter, we discuss pharmacovigilance in the context of biologics and biosimilars and ensuring traceability.

Please wait while flipbook is loading. For more related info, FAQs and issues please refer to DearFlip WordPress Flipbook Plugin Help documentation.

Share content

Other learning chapters

Biosimilars in practice

Chapter 9

Biosimilars in practice

Detailing what to consider when reviewing a biosimilar for inclusion in a formulary and the role of pharmacists in implementing biosimilars into the health service
View chapter
Patient considerations and communication

chapter 10

Patient considerations and communication

Discussing the educational needs of patients about biosimilars and the pharmacists’ role in delivering advice and support to patients taking biosimilars
View chapter
Protein biology and biologic medications

CHAPTER 1

Protein biology and biologic medications

Discussing the fundamentals of protein synthesis - a process that produces some of the most used biologics and their biosimilars
View chapter